42 posts from February 2010

February 26, 2010

This week, in response to the proposed 21% cut to Medicare reimbursement rates set to take effect on March 1, James Rohack, president of the American Medical Association (AMA), informed the organizations 250,000 membersabout their options – which include completely opting out of a Medicare contract.

Although CNN noted that Congress has at the last minute blocked those cuts from happening in seven of the last 8 years, Rohack and the AMA are no longer supporting any further "temporary fixes." In fact, the AMA wants the current law to be repealed and a new formula used "that more accurately reflects the cost of providing care" in determining Medicare reimbursement rates.

A permanent doc fix, which would correct this problem, is not part of any of the health care reform packages before congress including those previously endorsed by the AMA.

In preparing for the proposed cut, the AMA's Web site is providing information to doctors about how they can help their patients find other doctors if they decide to no longer accept Medicare. Additionally, members have asked the AMA to produce pamphlets with the same information that could be handed out to their patients.

One example that highlights the problem of Medicare reimbursement rates is Dr. Edward Kornel, a neurosurgeon based in White Plains, N.Y., who stopped seeing Medicare patients two years ago, along with his two colleagues who stopped in the past six months. While Dr. Kornel, who's been in practice for 27 years, said he had always accepted Medicare patients in the past, he was losing money.

He told CNN that when he looked at his income from reimbursements, he was losing money every time he took care of a Medicare patient." He further added that the reimbursement rates were not covering his costs. Specifically, “while Medicare patients accounted for about 20% of his total patient load, they were generating less than 5% of his income.” Dr. Kornel said that he would have to do “300 operations in one year just to break even." In addition, the American Association of Neurological Surgeons (AANS), to which Kormel belongs, has “warned that Medicare patients would likely get less access to doctors if Medicare payment cuts continue.”

Despite Dr. Kornel’s experience, the “Center for Medicare and Medicaid Services (CMS) said that its own data, and other industry reports, show only a small percentage of beneficiaries unable to get physician access.” Such data are disputed however by the fact that a survey of AANS’s 3,400 members showed 65% was referring their Medicare patients to other doctors. In fact, about 60% said they were reducing the number ofMedicare patients in their practice, something AANS President Dr. Troy Tippet noted painted a “bleak path.”

Also echoing similar concerns was Dr. Priscilla Arnold, an ophthalmologist based in Bettendorf, Iowa, and past president of the American Society of Cataract and Refractive Surgery. Dr. Arnold told CNN that each year she is forced to “realistically evaluate” if she can continue to see all her patients. She also noted that the numbers from CMS did not account for doctors who are reducing the number of Medicare patients. As a result, if the cut is not changed, “many doctors in her specialty won't be able to sustain their practices.”

The concerns of these doctors should be echoed to your representatives and government officials before it’s too late. As Dr. Kornel asserted, "If doctors drop Medicare patients, people will be forced to go to clinics where it's hard to get appointments, the waits are long and you get far less attention than you would otherwise get." In order to avoid this potential “disaster” Congress needs to listen to patients and doctors before they have nowhere to go.

An article in Cardiology Today discusses why the term ‘conflict of interest’ is becoming an “outdated phrase for physician-industry relationships.” Specifically, the article recognized that while current conflict of interest policies (COI) are designed “in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry,” negative consequences can result.

In fact, many of the current COI policies “place limits on what physicians may and may not do regarding their involvement with activities and research funded by industry.” The result of such limitations has led “many institutions and publications to enact multifaceted disclosure and conflict of interest policies to avoid appearances of impropriety or unethical behavior.”

According to the newly formed Association of Clinical Researchers and Educators (ACRE), these new policies “may be mischaracterizing the nature of collaboration and downplaying the potential benefits of collaborations between physicians and industry.”

Supporters of such limitations, cite “data from 29 studies, and an often-cited JAMA review published in 2000 by Ashley Wazana, MD, an assistant professor at McGill University in Montreal.” In this study, Wazana suggested that the relationships between industry and physicians appear to affect prescribing and professional behavior, as well as continuing medical education sponsored by a drug company. Recent research, as we previously discussed from the Cleveland Clinic shows strong evidence to dispute such claims regarding CME.

Framing Bias, Terminology

Critics of the phrase ‘conflict of interest’ in the medical practice as it applies to industry-physician collaborative relationships believe the term “is fraught with philosophical and practical problems.” According to Michael Weber, MD, a professor of medicine at State University of New York Downstate Medical Center College of Medicine, “The term almost implies that in order to receive the funding to do the research, the physician had to do something that had an adversarial or negative impact on the patients he was caring for.

Dr. Weber told Cardiology Today “If I show that a cancer treatment prolongs somebody’s life by six months with this or that side effect, but I have also shown that the treatment is beneficial, I can disclose a financial interest so that one knows the providence of the research funding. Why, then, use the term ‘conflict?’”

Lance Stell, PhD, a professor of philosophy at Davidson College and a clinical professor of medicine at the University of North Carolina School of Medicine, noted that there is a “negative connotation inherent in the term.” Specifically, the term “conflict” established a “default moral judgment” and “makes salient one aspect of incentive misalignment and risk” while negating other “offsetting incentives, alignments and common interests.”

As a result, Stell asserted that this framing bias has “rhetorically reconstructed what were once termed “relationships” between physicians and industry and has instead designated them as conflicts.”

Thomas P. Stossel, MD, a professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, noted another problem in the current framing of industry-physician collaboration: “the misattribution of interests to the interested parties involved in the collaboration.”

Dr. Stossel told Cardiology Today that the current frame creates somewhat of a socialistic view that “there is a winner and there must be a loser.” He clarified that “in medicine, this view does not exist because there is “an alignment of interests, and it is win-win if it adds value.”

Regulations on Collaboration

Despite this framing bias, states such as Massachusetts, Vermont and Minnesota, as well as universities such as Harvard and the University of Wisconsin, have passed laws that place strict limits on the interactions that physicians can have with industry. In fact, Dr. Weber noted how the “University of Wisconsin, has proposed rules that would prevent their faculty from participating in educational activities that are funded by industry.” He asserted that such a rule “seems to not be based on any logic.”

Dr. Weber did believe that some policies, regulating speakers who are paid by industry can prevent problems for the speaker, patients and for industry. He asserted that a company who decides to hire a doctor to do promotional talks on a drug is appropriate because the speaker is “obligated to only say about the drug what is FDA-approved in the labeling of the drug, which is a reasonable requirement.”

Fruits of collaboration

Dr. Stell asserted that “patients ultimately end up deriving benefits from collaboration,” citing devices that came about as a result of industry-physician collaborations such as the “intra-aortic balloon pumps, multilumen catheters, trans-esophageal echocardiography, portable defibrillators, pulmonary catheters, arrhythmia ablation technologies and many others.” He also listed some commonly used drugs on the list including calcium channel blockers, erythropoietin, various statins, ACE inhibitors and PDE5 inhibitors, among many others.

Dr. Stossel recognized that because of industry-physician collaboration, “Medicine is incomparably better than when he started out practicing about 40 years ago.” He further emphasized that medicine today is better “not because doctors are now somehow more ethical or have been more heavily regulated – rather, it is because of the products that they have developed and gotten through their collaborations with industry.”

In agreement with his statements, Casey Kimmelstiel, MD, an associate professor of medicine and director of clinical cardiology at Tufts University School of Medicine, noted that “the benefits of the collaborations often outweigh the negatives.” Dr. Kimmelstiel emphasized that “the overwhelming majority of advances in medicine in the past century have been due to the collaborative relationship between industry and physicians – drugs, devices, vaccines, antibiotics, pacemakers, defibrillators, stents, cancer therapy, artificial hips and knees, HIV medications – the list goes on and on.”

ACRE

In 2008, ACRE formed in response to the growing criticism of physician-industry relationships, with the mission of educating professionals and policymakers on the value of the collaborative relationship between industry and researchers. ACRE also aims to provide a forum for like-minded physicians and industry partners to discuss and debate the relationship. Dr. Kimmelstiel added that “The goals of ACRE are really to highlight the value of collaboration between health care professionals and industry, as well as to provide education for health care professionals and patient advocates to empower them to reject this framing bias and fight those policies that undermine productive collaboration.”

He further noted that “The long-term goals of ACRE are to promote efficient patient care and efficient, effective collaboration in the pursuit of innovation that is based on good science. Most importantly, perhaps, it is to help train our current and next generation of physicians so that they can promote true excellence in medical education and innovation.”

Ultimately, over the past few decades, the only thing that has changed between physician-industry relationships is that they have grown to help and treat more patients with new research, advances and innovations. As a result, calling such relationships ‘conflicts’ today should be seriously reconsidered, before the next thing to change is that we see less relationships, and thus helping less patients.

February 25, 2010

Tonight at 8:00pm and 11:00pm EST on the Fox Businesses Channel, John Stossel, host of "Stossel" on the Fox Business Network, will discuss the issue of who should control what people put into their body, and in what sense people are free to decide what medicines they should take. In his opinion, “people suffer and die because the government "protects" us.” Accordingly, he believes that the government “should protect us less and respect our liberty more.”

On his program tonight he will speak with Bruce Tower, who is currently living with prostate cancer. Mr. Tower “wanted to take a drug that showed promise against his cancer, but the Food and Drug Administration would not allow it.” He was told by “one bureaucrat that the government was protecting him from dangerous side effects.”

Mr. Tower was outraged by such comments, and said “who cares about side effects?” As a terminally ill patient, who has experienced various treatments and suffered from side effects, he asserted that it should be his option to endure any side effects. Stossel agreed with this opinion that it “should be his option.” The talk show host was further frustrated by the fact that “Americans seem to stand aside and let the state limit their choices, even when people are dying.”

The show will also highlight Dr. Alan Chow, who invented a retinal implant that helps some blind people see (optobionics.com). It took him seven years and cost $50 million dollars of FDA-approved tests to develop it, “but now the FDA wants still more tests.” Dr. Chow however, does not have the additional $100 million needed, and the third stage will take another three years. He is also faced with problems raising money from “investors because the implant only helps some blind people, and investors fear there are too few customers to justify their $100 million risk.”

As a result, patients like “Stephen Lonegan, who has a degenerative eye disease that might be helped by the implant, can't have it,” and instead, he will go blind. Mr. Lonegan asserted that he does not “want to be made safe by the FDA” and he would rather be able to see Dr. Chow “and make the decision himself.”

Stossel will use these cases to confront Terry Toigo of the FDA, who believes these “restrictions are necessary to protect the integrity of the government's safety review process.”He asked Toigo why the FDA had to be involved, and why people could not just try things. She replied, "We don't think that's the best system for patients, to enable people to just take whatever they want with little information available about a drug."

Stossel believed that preventing patients from choosing causes “people to suffer and die when they might have lived longer, more comfortable lives.”

His program will also focus on the “Drug Enforcement Agency's war on drug dealers,” which has led them to watch pain-management doctors like hawks.” He asserts that such watching scares “pain specialists into underprescribing painkillers, and as a result, sick people suffer horrible pain needlessly.”

Ultimately, Stossel correctly acknowledges that because we live in a free country, and all drugs involve risk, “it should be up to individuals, once we're adults, to make our own choices about those risks.”

Important to our industry one segment of the program will feature a mini debate between Thomas Stossel, MD and Arnold Relman, MD on the topic of industry physician relationships.

The show will air at 8pm and 11pm EST on Fox Business Network, be sure to tune in.